Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All Lot manufactured from 08/31/14 to 08/07/2019
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Western / Scott Fetzer Company
Reason for Recall:
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

Product Codes/Lot Numbers:

All Lot manufactured from 08/31/14 to 08/07/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0340-2020

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Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

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Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

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Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

Aug 15, 2019 Diagnostic Equipment Nationwide View Details →